A Multidisciplinary Approach to Improve Adherence to Medical Recommendations in Older Adults

NCT ID: NCT05719870

Last Updated: 2023-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Background and overall goal: Poor comprehension and medication adherence are common in older people, especially after hospitalizations, in case of changes or prescriptions of new therapeutic regimes. The aim of this project is to evaluate the effectiveness of a multidomain intervention with an integrated care approach, in improving medication adherence in older people after hospital discharge. A secondary aim is investigate the determinants of poor comprehension and medication adherence in such individuals.

Target population: The project will involve older patients hospitalized in a Geriatric Department and discharged at home, and (when present) their caregivers.

Methods and assessments: Upon hospital discharge, data from the comprehensive geriatric assessment and information on the present hospitalization and prescribed therapies will be collected for all participants. The comprehension of medical recommendations reported in the discharge summary will be evaluated for all patients/caregiver before and after the routine explanation by treating physicians. Participants will be then randomized in intervention vs. control group. The intervention will include: first, educational training of patients/caregivers at hospital discharge by a multidisciplinary team; second, after hospital discharge, a phone recall on the prescribed therapies and a one-week phone consultant service managed by a geriatrician, supported by the multidisciplinary team, to address potential concerns on prescribed treatments. Control group will follow usual care. After 7 days medication adherence will be assessed for both study groups through structured phone interviews. At 30 and 90 days from discharge, data on falls, rehospitalizations and vital status will be collected through hospital records.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Background and overall goal: Poor comprehension and medication adherence are common in older people, especially after hospitalizations, in case of changes or prescriptions of new therapeutic regimes. The aim of this project is to evaluate the effectiveness of a multidomain intervention with an integrated care approach, in improving medication adherence in older people after hospital discharge. Moreover, a secondary aim is to investigate the determinants of poor comprehension and medication adherence in such individuals.

Target population: The project will involve older patients hospitalized in a Geriatric Department and discharged at home, and (when present) their caregivers.

Methods and assessments: Upon hospital discharge, data from the comprehensive geriatric assessment and information on the present hospitalization and prescribed therapies will be collected for all participants. The comprehension of medical recommendations reported in the discharge summary will be evaluated for all patients/caregiver before and after the routine explanation by treating physicians. Participants will be then randomized in intervention vs. control group. The intervention will include: first, educational training of patients/caregivers at hospital discharge by a multidisciplinary team; second, after hospital discharge, a phone recall on the prescribed therapies and a one-week phone consultant service managed by a geriatrician, supported by the multidisciplinary team, to address potential concerns on prescribed treatments. Control group will follow usual care. After 7, 30 and 90 days, data on medication adherence, falls, rehospitalizations and vital status will be assessed for both study groups through structured phone interviews and hospital records.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Medication Adherence Aging Multidisciplinary Communication Fall Hospital Discharge

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized to the intervention vs. control group. The intervention will include: first, educational training of patients/caregivers at hospital discharge by a multidisciplinary team; second, after hospital discharge, a phone recall on the prescribed therapies and a one-week phone consultant service managed by a geriatrician, supported by the multidisciplinary team, to address potential concerns on prescribed treatments. Control group will follow usual care.

After 7 days medication adherence will be assessed for both study groups through structured phone interviews.

Over 30 and 90 days from discharge, data on falls, rehospitalizations and vital status will be collected through hospital records.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group

Patients hospitalized in the Geriatric Unit aged 60 years or older, that living in the community setting and who will be discharged at home and with expected survival \>7 days.

Group Type EXPERIMENTAL

Educational training

Intervention Type BEHAVIORAL

The intervention will include: first, educational training of patients/caregivers at hospital discharge by a multidisciplinary team; second, after hospital discharge, a phone recall on the prescribed therapies and a one-week phone consultant service managed by a geriatrician, supported by the multidisciplinary team, to address potential concerns on prescribed treatments.

Control group

Patients hospitalized in the Geriatric Unit aged 60 years or older, that living in the community setting and who will be discharged at home and with expected survival \>7 days.

The control group will be discharged following standard care procedures, and will receive only appropriate corrections and clarifications in case mistakes in the comprehension of the medical recommendations.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Educational training

The intervention will include: first, educational training of patients/caregivers at hospital discharge by a multidisciplinary team; second, after hospital discharge, a phone recall on the prescribed therapies and a one-week phone consultant service managed by a geriatrician, supported by the multidisciplinary team, to address potential concerns on prescribed treatments.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients hospitalized in the Geriatric Units of the Padua and Ferrara University Hospitals
* Age 60 years or older
* Patients living in the community setting and who will be discharged at home
* Expected survival \>7 days

Exclusion Criteria

* Patients discharged in long-term care facilities or other acute or post-acute wards
* No consent to participate in the study.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Padova

OTHER

Sponsor Role collaborator

University Hospital of Ferrara

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cateriina Trevisan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Ferrara

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Geriatric Unit of Ferrara Hospital

Ferrara, , Italy

Site Status RECRUITING

Geriatric Unit of the Padua Central Hospital

Padua, , Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Giuseppe Sergi, MD, PhD

Role: CONTACT

0498218492

Caterina Trevisan, MD, PhD

Role: CONTACT

0532239572

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Caterina Trevisan

Role: primary

0532239572

Giuseppe Sergi

Role: primary

0498218492

References

Explore related publications, articles, or registry entries linked to this study.

Zanforlini BM, Sambo S, Devita M, Cignarella A, Vezzali F, Sturani S, Grandieri A, Noale M, Siviero P, Limongi F, Volpato S, Sergi G, Trevisan C; APPROACH working group. A multidisciplinary approach to improve adherence to medical recommendations in older adults at hospital discharge: The APPROACH study protocol. PLoS One. 2024 Apr 30;19(4):e0297238. doi: 10.1371/journal.pone.0297238. eCollection 2024.

Reference Type DERIVED
PMID: 38687693 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

947/2021/SPER/AOUFe

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Medication Adherence Program
NCT05183763 RECRUITING NA
Effect of Reminders on Adherence
NCT02411006 COMPLETED NA